Oral Lichen PlanusNCT07721090
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
A study testing Pharmacist-Led Prescribing Optimization and Patient Counselling in people with Oral Lichen Planus and Recurrent Aphthous Stomatitis, run by University of Fujairah.
Trial summary
This study aims to improve how oral mucosal disorders-such as oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, herpes viral infection and oral candidiasis-are treated in dental settings. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Lichen Planus, Recurrent Aphthous Stomatitis, Burning Mouth Syndrome
- What is being tested?
- Pharmacist-Led Prescribing Optimization and Patient Counselling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and above
- Diagnosed with an oral mucosal disorder (oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, Herpes viral infection or oral candidiasis)
- Attending participating dental clinic sessions during the study period
- Prescribed pharmacological treatment for the oral mucosal condition
- Able and willing to provide written informed consent
Who cannot join
- Patients without a confirmed diagnosis of an oral mucosal disorder
- Patients requiring immediate emergency care or hospitalization
- Patients currently enrolled in another interventional clinical trial
- Known hypersensitivity to commonly prescribed medications used in the study
- Patients unable to comply with follow-up or study procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pharmacological Management Optimization for Oral Mucosal Disorders: A Clinical Pharmacist Led Cluster Randomized Controlled Trial With Implementation Science Evaluation
This study aims to improve how oral mucosal disorders-such as oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, herpes viral infection and oral candidiasis-are treated in dental settings. A pharmacist will work with dentists to review prescriptions, provide feedback, counsel patients, and monitor medication safety. Dental clinics will be assigned to either the pharmacist-led model or usual care. The study will evaluate whether this approach improves prescribing quality, patient adherence, symptom control, and safety. The findings may help establish a more standardized, effective way to manage these common oral conditions in routine dental practice.
Read the detailed description
This is a cluster-randomized interventional study evaluating a pharmacist-led model to improve prescribing quality and patient outcomes in the management of oral mucosal disorders. Dental clinic sessions (clusters) will be assigned to either an intervention arm or a usual-care control arm. The study includes patients diagnosed with oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, herpes viral infection or oral candidiasis.
In the intervention clusters, a clinical pharmacist will support dentists through structured prescription audits, evidence-based feedback, standardized drug algorithms, patient counselling, and monitoring of medication adherence and adverse drug reactions. Control clusters will continue routine dental care without pharmacist involvement.
The study will begin with an external pilot phase to assess feasibility, refine workflows, and finalize study tools, followed by a baseline phase and then full implementation of the cluster-randomized trial. Primary outcomes include prescribing guideline concordance. Secondary outcomes include patient adherence, symptom severity, quality of life, and medication safety.
Process and implementation outcomes will be evaluated using the Capability-Opportunity-Motivation Behaviour (COM-B) model and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to assess acceptability, feasibility, and sustainability of the intervention in real-world dental practice.
- Conditions
- Oral Lichen Planus, Recurrent Aphthous Stomatitis, Burning Mouth Syndrome, Oral Candidiasis, Herpes Virus Infection
- Being tested
- Pharmacist-Led Prescribing Optimization and Patient Counselling
- Keywords
- Oral Mucosal Diseases, Oral Lichen Planus, Recurrent Aphthous Stomatitis, Burning Mouth Syndrome, Oral Candidiasis, Medication Therapy Management, Drug Prescriptions, Patient Compliance
- Medical subject headings
- Lichen Planus, Oral, Stomatitis, Aphthous, Burning Mouth Syndrome, Candidiasis, Oral, Herpesviridae Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Led Prescribing Optimization and Patient CounsellingBehavioural
This intervention involves a structured, pharmacist-led model integrated into routine dental care for patients with oral mucosal disorders. A clinical pharmacist will review dental prescriptions using standardized, evidence-based drug algorithms; provide audit and feedback to dentists; deliver structured patient counselling focused on correct medication use and adherence; and monitor for adverse drug reactions using validated tools. The intervention targets improvement in prescribing quality, medication safety, and patient outcomes, without introducing investigational drugs or altering standard treatment choices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: Pharmacist-Led Prescribing Optimization | Experimental | Participants in this arm will receive usual dental care supplemented by a pharmacist-led intervention. A clinical pharmacist will conduct structured prescription audits, provide evidence-based feedback to dentists, apply standardized drug algorithms for oral mucosal disorders, deliver patient counselling on medication use and adherence, and monitor adverse drug reactions. Medications prescribed may include topical corticosteroids (e.g., clobetasol propionate 0.05% gel/ointment applied 2-3 times daily for 2-4 weeks, fluticasone propionate spray off-label), topical antifungals (e.g., nystatin oral suspension or miconazole oral gel), and other supportive therapies as per standard care. The intervention continues throughout the study period. Receives: Behavioral: Pharmacist-Led Prescribing Optimization and Patient Counselling |
| Control Arm: Usual Dental Care | No intervention | Participants in this arm will receive routine dental care for oral mucosal disorders according to existing clinical practice. Prescriptions, counselling, and follow-up will be provided at the discretion of the treating dentist, without pharmacist-led prescription audit, structured feedback, standardized counselling, or formal adverse drug reaction monitoring as part of the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescribing Guideline Concordance
Proportion of prescriptions that are fully concordant with predefined, evidence-based treatment guidelines for oral mucosal disorders, as assessed using a standardized prescription audit checklist.
Measured: Through the 9-month intervention phase (Months 4-12)
Secondary outcomes (5)
Medication adherence rate (%)
Percentage of prescribed doses taken, determined using a standardized adherence assessment combining self-reported adherence with objective measures (pill count or topical medication usage assessment, as applicable).
Measured: At baseline and at the end of the 9-month intervention phase (Month 12)
Symptom Severity
Change in patient-reported symptom severity (pain/burning sensation) measured using a numeric rating scale (0-10).
Measured: At baseline and at the end of the 9-month intervention phase (Month 12)
Oral Health-Related Quality of Life
Change in oral health-related quality of life measured using the Oral Health Impact Profile-14 (OHIP-14). The OHIP-14 total score ranges from 0 to 28, with higher scores indicating poorer oral health-related quality of life.
Measured: At baseline and at the end of the 9-month intervention phase (Month 12)
Adverse Drug Reactions (ADR)
Incidence, type, severity, causality (WHO-UMC), and preventability (Schumock and Thornton criteria) of adverse drug reactions related to prescribed medications.
Measured: Through study completion (18 months)
Patient Counselling Quality
Completion and quality of pharmacist-led counselling assessed using a standardized counselling checklist.
Measured: Throughout the 9-month intervention phase (Months 4-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Fujairah
- Sponsor type
- University, hospital or other
- Collaborators
- Sri Balaji Vidyapeeth University
- Responsible party
- Principal investigator, Nabeel Ayappali Kalluvalappil, University of Fujairah
- Investigators
- Tamer Hassan, Study chair, Gulf Medical UniversityRamam Sripada, Study director, Sri Balaji Vidyapeeth UniversityNasma Pulikkalakath, Principal investigator, Sri Balaji Vidyapeeth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721090
- Sponsor's protocol ID
- EA#65
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harden SM, Gaglio B, Shoup JA, Kinney KA, Johnson SB, Brito F, Blackman KC, Zoellner JM, Hill JL, Almeida FA, Glasgow RE, Estabrooks PA. Fidelity to and comparative results across behavioral interventions evaluated through the RE-AIM framework: a systematic review. Syst Rev. 2015 Nov 8;4:155. doi: 10.1186/s13643-015-0141-0.
PubMed 26547687Willmott TJ, Pang B, Rundle-Thiele S. Capability, opportunity, and motivation: an across contexts empirical examination of the COM-B model. BMC Public Health. 2021 May 29;21(1):1014. doi: 10.1186/s12889-021-11019-w.
PubMed 34051788Papagiannopoulou V, Oulis CJ, Papaioannou W, Antonogeorgos G, Yfantopoulos J. Validation of a Greek version of the oral health impact profile (OHIP-14) for use among adults. Health Qual Life Outcomes. 2012 Jan 14;10:7. doi: 10.1186/1477-7525-10-7.
PubMed 22244162Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.
PubMed 28217433Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.
PubMed 34760748Rohay JM, Dunbar-Jacob JM. Variation in adherence measures as a function of calculation methods. Front Pharmacol. 2024 Nov 13;15:1460327. doi: 10.3389/fphar.2024.1460327. eCollection 2024.
PubMed 39611172Yoshida K, Watanabe S, Hoshino N, Pak K, Hidaka N, Konno N, Nakai M, Ando C, Yabuki T, Suzuki N, Katsura K, Tomihara K, Toyama A. Hospital pharmacist interventions for the management of oral mucositis in patients with head and neck cancer receiving chemoradiotherapy: a multicenter, prospective cohort study. Support Care Cancer. 2023 May 3;31(5):316. doi: 10.1007/s00520-023-07784-6.
PubMed 37133630Bakhshi F, Mitchell R, Khosravi A, Antikchi M. Guideline adherence for controlling incidence of medication errors: a systematic mixed-method review. Int J Pharm Pract. 2025 Oct 3;33(5):477-493. doi: 10.1093/ijpp/riaf049.
PubMed 40650560Shetty Y, Kamat S, Tripathi R, Parmar U, Jhaj R, Banerjee A, Balakrishnan S, Trivedi N, Chauhan J, Chugh PK, Tripathi CD, Badyal DK, Solomon L, Kaushal S, Gupta K, Jayanthi M, Jeevitha G, Chatterjee S, Samanta K, Desai C, Shah S, Medhi B, Joshi R, Prakash A, Gupta P, Roy A, Chandy S, Ranjalkar J, Bright HR, Dikshit H, Mishra H, Roy SS, Kshirsagar N. Evaluation of prescriptions from tertiary care hospitals across India for deviations from treatment guidelines & their potential consequences. Indian J Med Res. 2024 Feb 1;159(2):130-141. doi: 10.4103/ijmr.ijmr_2309_22. Epub 2024 Apr 4.
PubMed 38528817Teoh L, Moses G, McCullough MJ. A review and guide to drug-associated oral adverse effects-Oral mucosal and lichenoid reactions. Part 2. J Oral Pathol Med. 2019 Aug;48(7):637-646. doi: 10.1111/jop.12910. Epub 2019 Jun 26.
PubMed 31241804Stoopler ET, Villa A, Bindakhil M, Diaz DLO, Sollecito TP. Common Oral Conditions: A Review. JAMA. 2024 Mar 26;331(12):1045-1054. doi: 10.1001/jama.2024.0953.
PubMed 38530258
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Management Optimization for Oral Mucosal Disorders: A Clinical Pharmacist Led Cluster Randomized Controlled Trial With Implementation Science Evaluation
- ClinicalTrials.gov ID
- NCT07721090
- Acronym / sponsor ID
- EA#65
- Conditions
- Oral Lichen Planus, Recurrent Aphthous Stomatitis, Burning Mouth Syndrome, Oral Candidiasis, Herpes Virus Infection
- Keywords
- Oral Mucosal Diseases, Oral Lichen Planus, Recurrent Aphthous Stomatitis, Burning Mouth Syndrome, Oral Candidiasis, Medication Therapy Management, Drug Prescriptions, Patient Compliance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- University of FujairahUniversity, hospital or other
- Collaborators
- Sri Balaji Vidyapeeth University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to improve how oral mucosal disorders-such as oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, herpes viral infection and oral candidiasis-are treated in dental settings. A pharmacist will work with dentists to review prescriptions, provide feedback, counsel patients, and monitor medication safety. Dental clinics will be assigned to either the pharmacist-led model or usual care. The study will evaluate whether this approach improves prescribing quality, patient adherence, symptom control, and safety. The findings may help establish a more standardized, effective way to manage these common oral conditions in routine dental practice.
Detailed description
This is a cluster-randomized interventional study evaluating a pharmacist-led model to improve prescribing quality and patient outcomes in the management of oral mucosal disorders. Dental clinic sessions (clusters) will be assigned to either an intervention arm or a usual-care control arm. The study includes patients diagnosed with oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, herpes viral infection or oral candidiasis.
In the intervention clusters, a clinical pharmacist will support dentists through structured prescription audits, evidence-based feedback, standardized drug algorithms, patient counselling, and monitoring of medication adherence and adverse drug reactions. Control clusters will continue routine dental care without pharmacist involvement.
The study will begin with an external pilot phase to assess feasibility, refine workflows, and finalize study tools, followed by a baseline phase and then full implementation of the cluster-randomized trial. Primary outcomes include prescribing guideline concordance. Secondary outcomes include patient adherence, symptom severity, quality of life, and medication safety.
Process and implementation outcomes will be evaluated using the Capability-Opportunity-Motivation Behaviour (COM-B) model and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to assess acceptability, feasibility, and sustainability of the intervention in real-world dental practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Pharmacist-Led Prescribing Optimization | Experimental | Behavioral: Pharmacist-Led Prescribing Optimization and Patient CounsellingParticipants in this arm will receive usual dental care supplemented by a pharmacist-led intervention. A clinical pharmacist will conduct structured prescription audits, provide evidence-based feedback to dentists, apply standardized drug algorithms for oral mucosal disorders, deliver patient counselling on medication use and adherence, and monitor adverse drug reactions. Medications prescribed may include topical corticosteroids (e.g., clobetasol propionate 0.05% gel/ointment applied 2-3 times daily for 2-4 weeks, fluticasone propionate spray off-label), topical antifungals (e.g., nystatin oral suspension or miconazole oral gel), and other supportive therapies as per standard care. The intervention continues throughout the study period. |
| Control Arm: Usual Dental Care | No intervention | –Participants in this arm will receive routine dental care for oral mucosal disorders according to existing clinical practice. Prescriptions, counselling, and follow-up will be provided at the discretion of the treating dentist, without pharmacist-led prescription audit, structured feedback, standardized counselling, or formal adverse drug reaction monitoring as part of the study protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years and above
- Diagnosed with an oral mucosal disorder (oral lichen planus, recurrent aphthous stomatitis, burning mouth syndrome, Herpes viral infection or oral candidiasis)
- Attending participating dental clinic sessions during the study period
- Prescribed pharmacological treatment for the oral mucosal condition
- Able and willing to provide written informed consent
Key exclusion criteria (5 listed)
- Patients without a confirmed diagnosis of an oral mucosal disorder
- Patients requiring immediate emergency care or hospitalization
- Patients currently enrolled in another interventional clinical trial
- Known hypersensitivity to commonly prescribed medications used in the study
- Patients unable to comply with follow-up or study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-Led Prescribing Optimization and Patient CounsellingThis intervention involves a structured, pharmacist-led model integrated into routine dental care for patients with oral mucosal disorders. A clinical pharmacist will review dental prescriptions using standardized, evidence-based drug algorithms; provide audit and feedback to dentists; deliver structured patient counselling focused on correct medication use and adherence; and monitor for adverse drug reactions using validated tools. The intervention targets improvement in prescribing quality, medication safety, and patient outcomes, without introducing investigational drugs or altering standard treatment choices. | Behavioural | Intervention Arm: Pharmacist-Led Prescribing Optimization |
Primary outcome
Prescribing Guideline Concordance
Time frame: Through the 9-month intervention phase (Months 4-12)
Proportion of prescriptions that are fully concordant with predefined, evidence-based treatment guidelines for oral mucosal disorders, as assessed using a standardized prescription audit checklist.
5 secondary outcomes
Medication adherence rate (%)
Time frame: At baseline and at the end of the 9-month intervention phase (Month 12)
Symptom Severity
Time frame: At baseline and at the end of the 9-month intervention phase (Month 12)
Oral Health-Related Quality of Life
Time frame: At baseline and at the end of the 9-month intervention phase (Month 12)
Adverse Drug Reactions (ADR)
Time frame: Through study completion (18 months)
Patient Counselling Quality
Time frame: Throughout the 9-month intervention phase (Months 4-12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 26547687Harden SM, Gaglio B, Shoup JA, Kinney KA, Johnson SB, Brito F, Blackman KC, Zoellner JM, Hill JL, Almeida FA, Glasgow RE, Estabrooks PA. Fidelity to and comparative results across behavioral interventions evaluated through the RE-AIM framework: a systematic review. Syst Rev. 2015 Nov 8;4:155. doi: 10.1186/s13643-015-0141-0.
- Background: PubMed 34051788Willmott TJ, Pang B, Rundle-Thiele S. Capability, opportunity, and motivation: an across contexts empirical examination of the COM-B model. BMC Public Health. 2021 May 29;21(1):1014. doi: 10.1186/s12889-021-11019-w.
- Background: PubMed 22244162Papagiannopoulou V, Oulis CJ, Papaioannou W, Antonogeorgos G, Yfantopoulos J. Validation of a Greek version of the oral health impact profile (OHIP-14) for use among adults. Health Qual Life Outcomes. 2012 Jan 14;10:7. doi: 10.1186/1477-7525-10-7.
- Background: PubMed 28217433Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.
- Background: PubMed 34760748Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.
- Background: PubMed 39611172Rohay JM, Dunbar-Jacob JM. Variation in adherence measures as a function of calculation methods. Front Pharmacol. 2024 Nov 13;15:1460327. doi: 10.3389/fphar.2024.1460327. eCollection 2024.
- Background: PubMed 37133630Yoshida K, Watanabe S, Hoshino N, Pak K, Hidaka N, Konno N, Nakai M, Ando C, Yabuki T, Suzuki N, Katsura K, Tomihara K, Toyama A. Hospital pharmacist interventions for the management of oral mucositis in patients with head and neck cancer receiving chemoradiotherapy: a multicenter, prospective cohort study. Support Care Cancer. 2023 May 3;31(5):316. doi: 10.1007/s00520-023-07784-6.
- Background: PubMed 40650560Bakhshi F, Mitchell R, Khosravi A, Antikchi M. Guideline adherence for controlling incidence of medication errors: a systematic mixed-method review. Int J Pharm Pract. 2025 Oct 3;33(5):477-493. doi: 10.1093/ijpp/riaf049.
- Background: PubMed 38528817Shetty Y, Kamat S, Tripathi R, Parmar U, Jhaj R, Banerjee A, Balakrishnan S, Trivedi N, Chauhan J, Chugh PK, Tripathi CD, Badyal DK, Solomon L, Kaushal S, Gupta K, Jayanthi M, Jeevitha G, Chatterjee S, Samanta K, Desai C, Shah S, Medhi B, Joshi R, Prakash A, Gupta P, Roy A, Chandy S, Ranjalkar J, Bright HR, Dikshit H, Mishra H, Roy SS, Kshirsagar N. Evaluation of prescriptions from tertiary care hospitals across India for deviations from treatment guidelines & their potential consequences. Indian J Med Res. 2024 Feb 1;159(2):130-141. doi: 10.4103/ijmr.ijmr_2309_22. Epub 2024 Apr 4.
- Background: PubMed 31241804Teoh L, Moses G, McCullough MJ. A review and guide to drug-associated oral adverse effects-Oral mucosal and lichenoid reactions. Part 2. J Oral Pathol Med. 2019 Aug;48(7):637-646. doi: 10.1111/jop.12910. Epub 2019 Jun 26.
- Background: PubMed 38530258Stoopler ET, Villa A, Bindakhil M, Diaz DLO, Sollecito TP. Common Oral Conditions: A Review. JAMA. 2024 Mar 26;331(12):1045-1054. doi: 10.1001/jama.2024.0953.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamer Hassan study chair
Gulf Medical University
Ramam Sripada study director
Sri Balaji Vidyapeeth University
Nasma Pulikkalakath principal investigator
Sri Balaji Vidyapeeth University
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-Led Prescribing Optimization and Patient Counselling in people with Oral Lichen Planus and Recurrent Aphthous Stomatitis, run by University of Fujairah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabeel Ayappali Kalluvalappil (+97192023517, n.kalluvalappil@fu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescribing Guideline Concordance (time frame: Through the 9-month intervention phase (Months 4-12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07721090, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.